The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
How the addition of "Risk" will affect ISO 9001:2015
UL - Underwriters Laboratories - Health Sciences
How the addition of "Risk" will affect ISO 9001:2015
How the addition of "Risk" will affect ISO 9001:2015
How the addition of "Risk" will affect ISO 9001:2015
How the addition of "Risk" will affect ISO 9001:2015
How the addition of "Risk" will affect ISO 9001:2015
How the addition of "Risk" will affect ISO 9001:2015
How the addition of "Risk" will affect ISO 9001:2015
How the addition of "Risk" will affect ISO 9001:2015
How the addition of "Risk" will affect ISO 9001:2015
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

How the addition of "Risk" will affect ISO 9001:2015


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
iso 31000 - risk management, iso 9001 - quality management systems, iso 9001:2015, risk based thinking (rbt), risk management and analysis
Reply
 
Thread Tools Search this Thread Rating: Thread Rating: 2 votes, 5.00 average. Display Modes
  Post Number #1  
Old 14th August 2013, 04:53 PM
WCHorn's Avatar
WCHorn

 
 
Total Posts: 194
Question How the addition of "Risk" will affect ISO 9001:2015

Here is a link to a Quality Digest article that discusses the draft and "risk." I love the quote at the end of the article; "risk analysis is by definition a risky business."
Thank You to WCHorn for your informative Post and/or Attachment!

Sponsored Links
  Post Number #2  
Old 15th August 2013, 09:22 AM
Marc's Avatar
Marc

 
 
Total Posts: 25,940
Re: How the addition of "Risk" will affect ISO 9001:2015

I copied the above over from another thread for discussion here of "Risk" in the upcoming standard.

The focus shift to "Processes" in 2000 wasn't too big a hurdle. How do you envision "Risk" in terms of ISO 9001:2015?

4.4.2 - Process approach
“The organization shall:
d) determine the risks to conformity of goods and services and customer satisfaction if unintended outputs are delivered or process interaction is ineffective;”

5.1.2 - Leadership and commitment with respect to the needs and expectations of customers
“Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:
a) the risks which can affect conformity of goods and services and customer satisfaction are identified and addressed;”

6.1 - Actions to address risks and opportunities

“When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 (4.2 Understanding the needs and expectations of interested parties) and determine the risks and opportunities that need to be addressed to:
a) assure the quality management system can achieve its intended outcome(s)
b) assure that the organization can consistently achieve conformity of goods and services and customer satisfaction
c) prevent, or reduce, undesired effects, and
d) achieve continual improvement.”


Also notice opportunities in 6.1 a)

“The organization shall plan:
a) actions to address these risks and opportunities, and
b) how to:
1) integrate and implement the actions into its quality management system processes (see 4.4), and
2) evaluate the effectiveness of these actions.

Any actions taken to address risks and opportunities shall be proportionate to the potential effects on conformity of goods and services and customer satisfaction.”

8.3 - Operational planning process

“In preparing for the realization of goods and services, the organization shall implement a process to determine the following, as appropriate:
b) actions to identify and address risks related to achieving conformity of goods and services to requirements;”

8.5.1 - Development processes

“In determining the stages and controls for the development processes, the organization shall take account of:
e) the determined risks and opportunities associated with the development activities with respect to
1) the nature of the goods and services to be developed and potential consequences of failure
2) the level of control expected of the development process by customers and other relevant interested parties, and
3) the potential impact on the organization’s ability to consistently meet customer requirements and enhance customer satisfaction.”

8.6.5 - Post delivery activities

“The extent of post delivery activities that are required shall take account of:
a) the risks associated with the goods and services”

More "Risks" noted in:
9.1 - Monitoring, measurement, analysis and evaluation
9.2 - Internal audit
10.2 - Improvement
****************************
Your thoughts?
Thank You to Marc for your informative Post and/or Attachment!
Sponsored Links

  Post Number #3  
Old 15th August 2013, 10:03 AM
PaulJSmith's Avatar
PaulJSmith

 
 
Total Posts: 563
Re: How the addition of "Risk" will affect ISO 9001:2015

Will the standard contain a definition of "risk"? I haven't seen that yet. Does it reference ISO 31000 for the definition?
  Post Number #4  
Old 15th August 2013, 10:15 AM
Marc's Avatar
Marc

 
 
Total Posts: 25,940
Re: How the addition of "Risk" will affect ISO 9001:2015

ISO 31000 isn't in the ISO 9001 Draft. I don't have the ISO 9000 Draft to know whether it's in there or not. I assume it will be. I didn't see it in James Lamprecht's article.
  Post Number #5  
Old 15th August 2013, 12:02 PM
Randy's Avatar
Randy

 
 
Total Posts: 8,571
Re: How the addition of "Risk" will affect ISO 9001:2015

Risk will probably be similar to this definition except related to quality:

"combination of the likelihood of an occurrence of a hazardous event or
exposure(s) and the severity of injury or ill health (3.8) that can be
caused by the event or exposure(s)"
  Post Number #6  
Old 15th August 2013, 12:13 PM
Boingo-boingo's Avatar
Boingo-boingo

 
 
Total Posts: 201
Re: How the addition of "Risk" will affect ISO 9001:2015

Quote:
In Reply to Parent Post by Marc View Post

I don't have the ISO 9000 Draft to know whether it's in there or not.
The definition of risk is in the ISO 9001 CD.
Quote:
3.09 risk: effect of uncertainty

Note 1 to entry: An effect is a deviation from the expected — positive or negative.
Note 2 to entry: Uncertainty is the state, even partial, of efficiency of information related to, understanding or knowledge of, an event, its consequence, or likelihood.
Note 3 to entry: Risk is often characterized by reference to potential events (ISO Guide 73, 3.5.1.3) and consequences (ISO Guide 73, 3.6.1.3), or a combination of these.
Note 4 to entry: Risk is often expressed in terms of a combination of the consequences of an event (including changes in circumstances) and the associated likelihood (ISO Guide 73, 3.6.1.1) of occurrence.
Thank You to Boingo-boingo for your informative Post and/or Attachment!
  Post Number #7  
Old 15th August 2013, 12:32 PM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,252
Re: How the addition of "Risk" will affect ISO 9001:2015

The essence in this is the emphasis put to the planning.
The PDCA approach nevertheless is the basis, however organizations who hardly planned could demonstrate a management system that aligned to the standard. It is a well known fact that the more time you put to planning, the execution gets that much easier, faster and result oriented. When you plan and consider almost all risks associated, you are in better shape to deal and the doing becomes that much more enjoyable.
When you push yourself to consider all possible risks, you end up sharpening your axe that much better.
Thank You to somashekar for your informative Post and/or Attachment!
  Post Number #8  
Old 15th August 2013, 01:38 PM
hogheavenfarm's Avatar
hogheavenfarm

 
 
Total Posts: 541
Re: How the addition of "Risk" will affect ISO 9001:2015

We currently utilize a PPAP process which includes a PFMEA, so this is not really anything new, but the "opportunity" wording is a bit confusing. While process improvement and product improvement is a good thing, it is also difficult to enact when all process changes have to be customer approved. Depending upon the corporate bureaucracy, this may not ever be possible. Once your production plan or manufacturing plan is approved, change, even positive change becomes difficult sometimes. Also, opportunities for improvement of product, process, or service are hard to see at the time your PPAP is filed at the beginning of a production run, these things become more evident later, and at that point you are dealing with CAPAs, NCR's, and all the other fun stuff, although that usually supplies the 'burning platform' to file the needed changes.
Thanks to hogheavenfarm for your informative Post and/or Attachment!
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >

Bookmarks



Visitors Currently Viewing this Thread: 3 (0 Registered Visitors (Members) and 3 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
What can be considered a "Post Delivery Activity" (ISO 9001:2015 Clause 8.5) kcoryell1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8 20th July 2017 01:21 AM
Easy Way of "Implementing" Risk in ISO 9001 2015 QAMTY ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7 3rd April 2017 01:50 AM
Including the Word "Risk" into the Quality Policy (ISO 9001:2015)? QAMTY ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4 15th February 2017 04:26 PM
"Partial Design" Designation and Applicable ISO 9001:2015 Exemptions MichelleMcR ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11 10th January 2017 10:41 AM
ISO 9001:2015 4.4.1 - Providing Evidence of QMS Processes "Shalls" ogghall ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9 3rd October 2016 02:02 AM



The time now is 10:39 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 
 
 


NOTE: This forum uses "Cookies"